736f9577-d8ff-45c7-8205-dfdb7193492f

SPL v5
SPL
SPL Set ID 736f9577-d8ff-45c7-8205-dfdb7193492f
Route
ophthalmic
Published
Effective Date 2022-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
polyvinyl alcohol, unspecified (14 mg)
Inactive Ingredients
benzalkonium chloride edetate disodium sodium chloride sodium phosphate, dibasic, anhydrous sodium phosphate, monobasic, anhydrous water sodium hydroxide hydrochloric acid

Identifiers & Packaging

Marketing Status
otc monograph final active Since 1998-03-01

Purpose

Eye lubricant

Description

Drug Facts


Medication Information

Uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Purpose

Eye lubricant

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information
  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed. RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive Ingredients

Benzalkonium Chloride 0.005% (preservative), Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

Description

Drug Facts

Questions?

call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST

Section 42229-5

Drug Facts

Section 50570-1
  • Do not use if imprinted seal on the bottle neck is broken or missing.
  • Do not use if solution changes color or becomes cloudy.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.
Section 51945-4

Principal Display Panel Text for Container Label:

NDC 17478-060-12

Artificial

Tears

Solution

Polyvinyl

Alcohol 1.4%

Lubricant

Eye Drops

Sterile

15 mL (0.5 fl. oz.)

Active Ingredient

Polyvinyl Alcohol 1.4%

Stop Use and Ask A Doctor If

you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Purpose

Eye lubricant

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information (Other information)
  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed. RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive Ingredients (Inactive ingredients)

Benzalkonium Chloride 0.005% (preservative), Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

Questions?

call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST

Section 42229-5 (42229-5)

Drug Facts

Section 50570-1 (50570-1)
  • Do not use if imprinted seal on the bottle neck is broken or missing.
  • Do not use if solution changes color or becomes cloudy.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.
Section 51945-4 (51945-4)

Principal Display Panel Text for Container Label:

NDC 17478-060-12

Artificial

Tears

Solution

Polyvinyl

Alcohol 1.4%

Lubricant

Eye Drops

Sterile

15 mL (0.5 fl. oz.)

Active Ingredient (Active ingredient)

Polyvinyl Alcohol 1.4%

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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